KMB — Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented Class II

FDA Device Classification

FDA product code KMB covers "Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented", a Class II medical device regulated under 21 CFR 888.3490. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants.

Classification Details

Product Code
KMB
Device Class
Class II
Regulation Number
888.3490
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes